Geriatric Communication Skills Training Program for Oncology Clinicians

February 19, 2024 updated by: Memorial Sloan Kettering Cancer Center

Geriatric Communication Skills Training Program for Oncology Clinicians to Improve Management of Care for Geriatrics Cancer Patients

The purpose of this study is to learn more about the effects of a training program designed to help doctors communicate better with older patients and their caregivers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Clinician Eligibility

  • MSK medical oncology Health Care Professionals (HCP) - specifically identified as Attendings, fellows, or Advance Practice Professional (APP) - either a Nurse Practitioner (NP) or Physician Assistant (PA) from GI, GU Oncology, Lymphoma, Bone Marrow Transplant or Geriatrics Service (five services with a large number of geriatric patients)
  • Willingness to be audio-recorded as per self-report
  • Clinician has individual clinic consultations with patients in the target population: 65 years of age and over, English speaking, and patients who have had a new visit within the last 6 months.

Patient Eligibility

  • MSK patients 65 years of age and over as per EMR
  • English speaking as per EMR
  • Being seen by one of the consented HCPs as per the HCP and/or electronic medical record (EMR)
  • Willingness to be audio-recorded as per self-report
  • Patient had their first visit with the clinician within the last 6 months

Caregiver Eligibility

  • English speaking as per EMR
  • Accompanying an MSK patient being seen by one of the consented HCPs as per the HCP and/or EMR

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GI/GU/Lymphoma Oncologists
Doctors specializing in treating gastrointestinal cancer (cancer of the stomach, pancreas, colon, etc.), genitourinary cancer (cancer of the genitals and urinary tract), and lymphoma (cancer affecting the blood and lymph nodes)
Behavioral: Self-Efficacy Assessment
Health Care Professional's self-efficacy will be assessed by 12 ratings of self-reported confidence from (1) "strongly disagree" to (5) "strongly agree" in module-specific topics both before and after the training.
Behavioral: UCLA Geriatrics Attitudes Scale
The UCLA Geriatrics Attitudes Scale is a 14-item scale developed to assess health care providers' attitudes toward older persons and caring for older patients.
Other Names:
  • Perceived Ageism
Behavioral: Course Evaluations
The evaluation surveys for each of the three modules will contain fifteen statements assessing post-training attitudes regarding the skills learned and application of skills in oncology clinical practice, measured on a 5-point Likert scale.
Active Comparator: Participants with GI/GU/Lymphoma Cancer
Patients of the physicians in group 1
Behavioral: The Consultation and Relational Empathy (CARE) questionnaire
The Consultation and Relational Empathy (CARE) questionnaire is a 10-item self-report scale that measures a patient's satisfaction with how empathic their health care providers (HCP) was within a specific consultation.
Other Names:
  • Perceived Empathy
Behavioral: Consumer Assessment of Health Care Providers and Systems Program (CAHPS)
Patients" perceptions of the quality of their interactions with their clinicians will be rated with 6 items from the Consumer Assessment of Health Care Providers and Systems Program (CAHPS)
Other Names:
  • Satisfaction with communication
Behavioral: Patient activation measure (PAM) scale
The PAM scale contains 22 items that assess patient engagement in their care process.
Other Names:
  • Patient Activation.
Active Comparator: Caregivers of Participants with GI/GU/Lymphoma Cancer
Family members or caregivers of the patients in group 2
Behavioral: The Consultation and Relational Empathy (CARE) questionnaire
The Consultation and Relational Empathy (CARE) questionnaire is a 10-item self-report scale that measures a patient's satisfaction with how empathic their health care providers (HCP) was within a specific consultation.
Other Names:
  • Perceived Empathy
Behavioral: Consumer Assessment of Health Care Providers and Systems Program (CAHPS)
Patients" perceptions of the quality of their interactions with their clinicians will be rated with 6 items from the Consumer Assessment of Health Care Providers and Systems Program (CAHPS)
Other Names:
  • Satisfaction with communication

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of Health Care Provider (HCP) training
Time Frame: 8 weeks
Measured by number of HCP successfully recruited for the training
8 weeks
Participants satisfaction with Health Care Provider (HCP) training
Time Frame: 1 week
Self-reported measure of satisfaction
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Smita Banerjee, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 16, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-183

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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